Effects of comprehensive cardiac rehabilitation on functional capacity and cardiovascular risk factors in Brazilians assisted by public health care: protocol for a randomized controlled trial.

Gabriela S S Chaves,Gabriela L M Ghisi,Paul Oh,Sherry L Grace,Raquel R Britto,Antonio L Ribeiro

doi:10.1590/bjpt-rbf.2014.0192

Abstract

ABSTRACTBackgroundCardiovascular Disease (CVD) is the leading burden of disease worldwide. Moreover, CVD-related death rates are considered an epidemic in low- and middle-income countries (LMICs). Research shows that cardiac rehabilitation (CR) participation reduces death and improves disability and quality of life. Given the growing epidemic of CVD in LMICs and the insufficient evidence about CR programs in these countries, a Randomized Control Trial (RCT) in Latin America is warranted.ObjectiveTo investigate the effects of comprehensive CR on functional capacity and cardiovascular risk factors.MethodThe design is a single-blinded RCT with three parallel arms: comprehensive CR (exercise + education) versus exercise-based CR versus wait-list control (no CR). The primary outcome will be measured by the Incremental Shuttle Walk Test. Secondary outcomes are risk factors (blood pressure, dyslipidemia, dysglycemia, body mass index and waist circumference); tertiary outcomes are heart health behaviors (exercise, medication adherence, diet, and smoking), knowledge, and depressive symptoms. The CR program is six months in duration. Participants randomized to exercise-based CR will receive 24 weeks of exercise classes. The comprehensive CR group will also receive 24 educational sessions, including a workbook. Every outcome will be assessed at baseline and 6-months later, and mortality will be ascertained at six months and one year.ConclusionThis will be the first RCT to establish the effects of CR in Latin America. If positive, results will be used to promote broader implementation of comprehensive CR and patient access in the region and to inform a larger-scale trial powered for mortality.

Highlights

The most prevalent non-communicable disease globally, namely cardiovascular disease (CVD), is the leading cause of mortality, with over 80% of the deaths occurring in low- and middle-income countries (LMICs)[1]
The study was submitted to Plataforma Brasil, and the research ethics approval has been secured from Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil (898.235) and York University, Toronto, ON, Canada (e2015-172)
Brazil was chosen as the initial MIC setting for testing because of (1) the great burden of CVD2, (2) the availability of country-specific Cardiac Rehabilitation (CR) guidelines[6], and (3) there has never been an Randomized Control Trial (RCT) of CR in South America to our knowledge[10]

Summary

Introduction

The most prevalent non-communicable disease globally, namely cardiovascular disease (CVD), is the leading cause of mortality, with over 80% of the deaths occurring in low- and middle-income countries (LMICs)[1]. In the MIC of Brazil, CVD is the leading cause of death. CVD was responsible for 29% of total mortality in 2010 (approximately 37,000 deaths/year)[2]. CR on functional capacity and risk factors appropriate long-term management if further acute events and other complications are to be reduced or avoided. Participation in CR has been shown to reduce morbidity and mortality by approximately 25% when compared to usual care in high-income countries[3]. Robust evidence demonstrates participation improves functional capacity, as well as risk factor burden, knowledge, heart health behaviors, and psychosocial well-being[3]. It is demonstrated to be cost-effective and “value for money”[5]

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Conclusion